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临床试验/NCT00636012
NCT00636012已完成不适用

Stimulation of Gastric Slow Waves by Acupuncture of St36 and Pe6 - a Randomized Single-blind Controlled Trial

Charite University, Berlin, Germany1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2008年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
65
试验地点
1
主要终点
increase of percentage of regular gastric slow waves in the acupuncture group compared to the control group

研究概览

简要总结

Aim of the study is to investigate specific effects of acupuncture points.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • healthy volunteers
  • BMI between 17.5 and 25
  • 3 hours before the experiment no food
  • 3 hours before the experiment only water, and 1 hour before the experiment no fluid intake
  • 4 hours before the experiment no smoking
  • informed consent

排除标准

  • acupuncture treatment during the last 12 months
  • chronic disease
  • regular intake of medication which influence autonomic nervous system or GI tract
  • pregnant or breast feeding
  • drug or substance abuse

结局指标

主要结局

increase of percentage of regular gastric slow waves in the acupuncture group compared to the control group

时间窗: baseline, acupuncture

次要结局

  • systolic blood pressure(baseline, acupuncture)
  • half cycles(baseline, acupuncture)
  • increase of percentage of regular gastric slow waves in acupuncture with stimulation compared to no stimulation(baseline, acupuncture)
  • diastolic blood pressure(baseline, acupuncture)
  • mean blood pressure(baseline, acupuncture)
  • variability of heart rate(baseline, acupuncture)
  • heart rate(baseline, acupuncture)
  • breathing rate(baseline, acupuncture)
  • skin conductance level(baseline, acupuncture)
  • total vascular resistance(baseline, acupuncture)
  • stroke volume(baseline, acupuncture)
  • correlation between percentage of regular gastric slow waves and secondary outcome measures(baseline, acupuncture)
  • impact of needle sensation on gastric slow waves(baseline, acupuncture)
  • impact of expectation on gastric slow waves(baseline, acupuncture)
  • impact of anxiety (state-trait-anxiety-inventory) on gastric slow waves(baseline, acupuncture)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Claudia M. Witt

Prof. Dr. med.

Charite University, Berlin, Germany

研究点 (1)

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